UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported)
August 11, 2023

SANUWAVE Health, Inc.
(Exact name of registrant as specified in its charter)

Nevada
000-52985
20-1176000
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

11495 Valley View Road, Eden Prairie, Minnesota
55344
(Address of principal executive offices)
(Zip Code)

Registrant’s telephone number, including area code
(770) 419-7525

N/A
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which
registered
N/A
N/A
N/A
Indicate by check mark whether the registration is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐



Item 2.02
Results of Operations and Financial Condition.

On August 11, 2023, SANUWAVE Health, Inc., a Nevada Corporation (the “Company”), issued a press release announcing its financial results for the second quarter ended June 30, 2023. As previously announced, a business update via conference call occurred today at 8:30 am EST. Materials are provided on the Company website www.sanuwave.com/investors.

The information in this Item 2.02 of this Current Report on Form 8-K and the exhibits attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit No.

Description
 
 

Press Release dated August 11, 2023
104

Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
SANUWAVE HEALTH, INC.
     
Dated: August 11, 2023
By:
/s/ Toni Rinow
 
Name:
Toni Rinow
 
Title:
Chief Financial Officer




Exhibit 99.1


SANUWAVE Announces Q2 2023 Financial Results

EDEN PRAIRIE, MN, AUGUST 11, 2023 – SANUWAVE Health, Inc. (the “Company” or “SANUWAVE”) (OTCQB: SNWV), a leading provider of next-generation FDA-approved wound care products, today announced its 2nd quarter 2023 results.
 
For the three months ended June 30, 2023:
 

Revenue for the three months ended June 30, 2023 totaled $4.7 million, an increase of 20%, as compared to $3.9 million for the same period of 2022. This growth falls within the previously provided guidance range of 15-25% for Q2 2023. Revenue for the six months ended June 30, 2023 totaled $8.5 million, an increase of 19%, as compared to $7.1 million for the same period of 2022.
 

49 UltraMist® systems were sold in Q2 2023, up from 28 in Q1 of this year.
 

UltraMist® consumables revenue increased 25% to $2.8 million, versus $2.2 million for the same quarter last year on a 14% increase in treatments.  Revenue growth outpaced treatments due to higher average sale prices.
 

UltraMist® consumables revenue was 59% of overall revenue for Q2, up from 56% in the prior year period. This was primarily driven by a larger installed base, improved pricing, and higher usage rates.
 

Gross margin as a percentage of revenue increased to 74% for the three months ended June 30, 2023, vs 72% for the same period last year, primarily driven by stronger pricing initiatives.
 

For the three months ended June 30, 2023, operating income totaled $0.9 million, which is an improvement of $4.0 million compared to the same period in 2022.  This number benefited from a $1.25 million one-time reversal of accrued expenses and was partially offset by a $224 thousand non-cash stock compensation issuance.
 

Net loss for the three months ended June 30, 2023 was $7.3 million, compared to a net income of $1.6 million for the same period in 2022. The increase in net loss for the three months ended June 30, 2023 was primarily due to continued non-cash losses on the fair value of derivative liabilities.
 

The Company anticipates third quarter 2023 revenue growth will fall within a range of 15-25% as compared to the third quarter of 2022.
 

Recent Highlights from Q2 2023:
 

Appointment of Morgan Frank as Chief Executive Officer in May.
 

Appointment of Andrew Walko as President and to head manufacturing in July.
 

Signing of Distribution Agreement with Pacific Medical, Inc. bringing its sales force of over 215 representatives covering 7 western states to the UltraMist line of directed energy wound care products.
 

In July 2023, the Company issued Asset-Backed Secured Promissory Notes for which it received total proceeds of approximately $3.0 million.
 

SANUWAVE showcased its innovative non-invasive, regenerative medicine solutions for the treatment of chronic wounds at the Leaders in Wound Healing Conference in New Orleans, Louisiana, the Symposium on Advanced Wound Care Spring in National Harbor, Maryland, and the EWMA 2023 Symposium in Milan, Italy.
 

Leading plastic surgeon, Dr. Johnson presented on UltraMist at the Serena Foundation Leadership in Wound Conference.
 
“We are pleased to have generated significant revenue growth in Q2 despite ongoing capacity constraints,” said CEO Morgan Frank. “It has been a challenging time at SANUWAVE, but as these results are beginning to show, our drive toward cost cutting, process optimization, and margin expansion is beginning to gain traction as we move toward our near-term goals of growth acceleration and operating profitability.  In the coming quarters, we aim to continue and build upon this trend as we break the production and supply chain logjams that have prevented us from realizing the potential of the UltraMist system.”

Guidance
 
The Company continued to have constrained inventory supply during Q2 2023 and anticipates this will improve in Q3, but remain a significant factor. The Company anticipates Q3 2023 revenue growth of approximately 15% to 25% year over year. SANUWAVE its constrained inventory supply will improve materially and enable an acceleration of revenue growth in Q4 2023.

As previously announced, a business update will occur via conference call on August 11, 2023.  Materials for the conference call at 8:30 a.m. EDT are included on the Company’s website, www.sanuwave.com/investors.
 
Telephone access is available by dialing the following numbers:
 
Conference ID:  13740603
 
Telephone access to the call will be available by dialing the following numbers:
 

Participant Listening: 1-877-407-0784 or 1-201-689-8560
 
OR click the Call me™ link for instant telephone access to the event.
 
https://callme.viavid.com/viavid/?callme=true&passcode=13732361&h=true&info=company&r=true&B=6
 
A replay will be made available through August 25, 2023:
Replay Dial-In: 1-844-512-2921 or 1-412-317-6671
Access ID: 13740603
 
About SANUWAVE
 
SANUWAVE Health is focused on the research, development, and commercialization of its patented, non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.
 
SANUWAVE’s end-to-end wound care portfolio of regenerative medicine products and product candidates help restore the body’s normal healing processes. SANUWAVE applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular conditions.
 
Forward-Looking Statements
 
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to future financial results, production expectations and constraints, and plans for future business development activities and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
 
CONTACT:
Investors@Sanuwave.com
 

PART I -- FINANCIAL INFORMATION
 
ITEM 1.
FINANCIAL STATEMENTS
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share data)
 
   
June 30, 2023
   
December 31, 2022
 
ASSETS
 
Current Assets:
           
Cash
 
$
332
   
$
1,153
 
Restricted Cash
   
850
     
-
 
Accounts receivable, net of allowance of $1,214 and $1,037, respectively
   
2,818
     
4,029
 
Inventory
   
900
     
868
 
Prepaid expenses and other current assets
   
1,201
     
570
 
Total Current Assets
   
6,101
     
6,620
 
Property, equipment and other, net
   
1,050
     
856
 
Intangible assets, net
   
4,786
     
5,137
 
Goodwill
   
7,260
     
7,260
 
Total Non-current Assets
   
13,096
     
13,253
 
Total Assets
 
$
19,197
   
$
19,873
 
                 
LIABILITIES
 
Current Liabilities:
               
Senior secured debt, in default
 
$
16,123
   
$
14,416
 
Convertible promissory notes payable
   
17,712
     
16,713
 
Convertible promissory notes payable, related parties
   
8,346
     
7,409
 
Bridge notes advance
   
1,476
     
-
 
Accounts payable
   
4,859
     
4,400
 
Accrued expenses
   
6,351
     
8,512
 
Factoring liabilities
   
1,213
     
2,130
 
Warrant liability
   
14,410
     
1,416
 
Accrued interest
   
6,174
     
4,052
 
Accrued interest, related parties
   
1,438
     
788
 
Current portion of contract liabilities
   
67
     
60
 
Other
   
1,108
     
291
 
Total Current Liabilities
   
79,277
     
60,187
 
Non-current Liabilities
               
Lease liabilities
   
515
     
438
 
Contract liabilities
   
215
     
230
 
Deferred tax liability
   
28
     
28
 
Total Non-currrent Liabilities
   
758
     
696
 
Total Liabilities
 
$
80,035
   
$
60,883
 
                 
Commitments and Contingencies (Footnote 13)
               
                 
STOCKHOLDERS’ DEFICIT
 
                 
Preferred Stock, par value $0.001, 5,000,000 shares authorized;
6,175 shares Series A, 293 shares Series B, 90 shares Series C and 8 shares Series D
no shares issued and outstanding at June 30, 2023 and December 31, 2022
 
$
-
   
$
-
 
Common Stock, par value $0.001, 2,500,000,000 shares authorized; 561,637,651 and 548,737,651
issued and outstanding at June 30, 2023 December 31, 2022, respectively
   
562
     
549
 
Additional paid-in capital
   
153,264
     
152,750
 
Accumulated deficit
   
(214,584
)
   
(194,242
)
Accumulated other comprehensive loss
   
(80
)
   
(67
)
Total Stockholders’ Deficit
   
(60,838
)
   
(41,010
)
Total Liabilities and Stockholders’ Deficit
 
$
19,197
   
$
19,873
 

 The accompanying notes to condensed consolidated financial statement are an integral part of these financial statements.


SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS)/INCOME
(UNAUDITED)
(In thousands, except share data)
 
   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2023
   
2022
   
2023
   
2022
 
Revenue
 
$
4,675
   
$
3,882
   
$
8,450
   
$
7,077
 
Cost of Revenues
   
1,202
     
1,096
     
2,464
     
1,986
 
Gross Margin
   
3,473
     
2,786
     
5,986
     
5,091
 
                                 
Operating Expenses:
                               
General and administrative
   
1,238
     
3,781
     
3,997
     
5,986
 
Selling and marketing
   
978
     
1,672
     
2,390
     
3,387
 
Research and development
   
139
     
171
     
270
     
337
 
Depreciation and amortization
   
187
     
210
     
376
     
386
 
Total Operating Expenses
   
2,542
     
5,834
     
7,033
     
10,096
 
                                 
Operating Income/(Loss)
   
931
     
(3,048
)
   
(1,047
)
   
(5,005
)
                                 
Other Income (Expense):
                               
Interest expense
   
(3,706
)
   
(2,903
)
   
(7,218
)
   
(6,040
)
Interest expense, related party
   
(675
)
   
(56
)
   
(1,441
)
   
(112
)
Change in fair value of derivative liabilities
   
(3,821
)
   
7,861
     
(10,618
)
   
11,343
 
Loss on issuance of debt
   
-
     
-
     
-
     
(3,434
)
Loss on extinguishment of debt
   
-
     
(211
)
   
-
     
(211
)
Other (expense) income
   
9
     
1
     
(18
)
   
2
 
Total Other (Expense)/Inocme
   
(8,193
)
   
4,692
     
(19,295
)
   
1,548
 
                                 
Net (Loss)/Income before Income Taxes
   
(7,262
)
   
1,644
     
(20,342
)
   
(3,457
)
                                 
Provision for Income Taxes
   
-
     
-
     
-
     
-
 
                                 
Net (Loss)/Income
   
(7,262
)
   
1,644
     
(20,342
)
   
(3,457
)
                                 
Other Comprehensive Loss
                               
Foreign currency translation adjustments
   
(9
)
   
-
     
(13
)
   
-
 
                                 
Total Comprehensive (Loss)/Income
 
$
(7,271
)
 
$
1,644
   
$
(20,355
)
 
$
(3,457
)
                                 
(Loss) income per Share:
                               
Basic
 
$
(0.01
)
 
$
-
   
$
(0.04
)
 
$
(0.01
)
Diluted
 
$
(0.01
)
 
$
-
   
$
(0.04
)
 
$
(0.01
)
Weighted average shares outstanding
                               
Basic
   
582,328,811
     
538,560,051
     
579,178,811
     
532,589,825
 
Diluted
   
582,328,811
     
871,984,091
     
579,178,811
     
532,589,825
 
 
The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(UNAUDITED)
(In thousands, except share data)
 
Three Months Ended June 30, 2023
 
   
Common Stock
   
Additional Paid-
in Capital
   
Accumulated
Deficit
   
Accumulated
Other
Comprehensive
Loss
   
Total
 
 
Number of
Shares
Issued and
Outstanding
   
Par Value
 
                                     
Balances as of March 31, 2023
   
555,637,651
   
$
556
   
$
153,046
   
$
(207,322
)
 
$
(71
)
 
$
(53,791
)
Shares issued for services
   
6,000,000
     
6
     
218
     
-
             
224
 
Net loss
   
-
     
-
     
-
     
(7,262
)
   
-
     
(7,262
)
Foreign currency translation adjustment
   
-
     
-
     
-
     
-
     
(9
)
   
(9
)
                                                 
Balances as of June 30, 2023
   
561,637,651
   
$
562
   
$
153,264
   
$
(214,584
)
 
$
(80
)
 
$
(60,838
)

Three Months Ended June 30, 2022
 
   
Common Stock
   
Additional Paid-
in Capital
   
Accumulated
Deficit
   
Accumulated
Other
Comprehensive
Loss
   
Total
 
   
Number of
Shares
Issued and
Outstanding
   
Par Value
 
                                   
Balances as of March 31, 2022
   
517,195,705
   
$
517
   
$
150,533
   
$
(189,050
)
 
$
(67
)
 
$
(38,067
)
Shares issued for services
   
12,097,500
     
12
     
876
     
-
     
-
     
888
 
Net Income
   
-
     
-
     
-
     
1,644
     
-
     
1,644
 
Foreign currency translation adjustment
   
-
     
-
     
-
     
-
             
-
 
                                                 
Balances as of June 30, 2022
   
529,293,205
   
$
529
   
$
151,409
   
$
(187,406
)
 
$
(67
)
 
$
(35,535
)

The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(UNAUDITED)
(In thousands, except share data)
 
Six Months Ended June 30, 2023
 
   
Common Stock
   
Additional Paid-
in Capital
   
Accumulated
Deficit
   
Accumulated
Other
Comprehensive
Loss
   
Total
 
   
Number of
Shares
Issued and
Outstanding
   
Par Value
 
                                     
Balances as of December 31, 2022
   
548,737,651
   
$
549
   
$
152,750
   
$
(194,242
)
 
$
(67
)
 
$
(41,010
)
Shares issued for services
   
12,900,000
     
13
     
514
     
-
     
-
     
527
 
Net loss
   
-
     
-
     
-
     
(20,342
)
   
-
     
(20,342
)
Foreign currency translation adjustment
   
-
     
-
     
-
     
-
     
(13
)
   
(13
)
                                                 
Balances as of June 30, 2023
   
561,637,651
   
$
562
   
$
153,264
   
$
(214,584
)
 
$
(80
)
 
$
(60,838
)

Six Months Ended June 30, 2022
 
   
Common Stock
   
Additional Paid-
in Capital
   
Accumulated
Deficit
   
Accumulated
Other
Comprehensive
Loss
   
Total
 
   
Number of
Shares
Issued and
Outstanding
   
Par Value
 
                                     
Balances as of December 31, 2021
   
481,619,621
   
$
482
   
$
144,582
   
$
(183,949
)
 
$
(73
)
 
$
(38,958
)
Cashless warrant exercise
   
14,000,000
     
14
     
2,152
     
-
     
-
     
2,166
 
Warrant exercise
   
909,091
     
1
     
99
     
-
     
-
     
100
 
Shares issued in conjunction with Note Payable
   
20,666,993
     
20
     
3,700
     
-
     
-
     
3,720
 
Shsares issued for services
   
12,097,500
     
12
     
876
     
-
     
-
     
888
 
Net loss
   
-
     
-
     
-
     
(3,457
)
   
-
     
(3,457
)
Foreign currency translation adjustment
   
-
     
-
     
-
     
-
     
6
     
6
 
                                                 
Balances as of June 30, 2022
    529,293,205    
$
529
   
$
151,409
   
$
(187,406
)
 
$
(67
)
 
$
(35,535
)

The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
 

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
 
   
Six Months Ended June 30,
 
   
2023
   
2022
 
Cash Flows - Operating Acivities:
           
Net loss
 
$
(20,342
)
 
$
(3,457
)
Adjustments to reconcile net loss to net cash used by operating activities
               
Depreciation and amortization
   
515
     
446
 
Bad debt expense
   
313
     
52
 
Shares issued for services
   
224
     
888
 
Change in fair value of derivative liabilities
   
10,618
     
(11,343
)
Loss on extinguishment of debt
   
-
     
211
 
Loss on issuance of debt
   
-
     
3,434
 
Amortization of debt issuance costs and original issue discount
   
3,955
     
1,304
 
Accrued interest
   
3,606
     
1,327
 
Changes in operating assets and liabilities
               
Accounts receivable - trade
   
898
     
733
 
Inventory
   
(31
)
   
115
 
Prepaid expenses and other assets
   
(336
)
   
(27
)
Accounts payable
   
718
     
(486
)
Accrued expenses
   
(1,337
)
   
1,710
 
Contract liabilties
   
(16
)
   
(108
)
Net Cash Used in Operating Activities
   
(1,215
)
   
(5,201
)
                 
Cash Flows - Investing Activities
               
Proceeds from sale of property and equipment
   
-
     
948
 
Purchase of property and equipment
   
(169
)
   
-
 
Net Cash Flows (Used in)/Provided by Investing Activities
   
(169
)
   
948
 
                 
Cash Flows - Financing Activities
               
Proceeds from senior promissory notes
   
-
     
2,940
 
Proceeds from convertible promissory notes payable
   
1,202
     
-
 
Proceeds from bridge notes advance
   
1,476
     
2,130
 
Payments to factoring agent, net
   
(1,167
)
   
55
 
Proceeds from warrant exercises
   
-
     
100
 
Payments of principal on finance leases
   
(85
)
   
(121
)
Net Cash Flows Provided by Financing Activities
   
1,426
     
5,104
 
                 
Effect of Exchange Rates on Cash
   
(13
)
   
14
 
                 
Net Change in Cash and Restricted Cash During Period
   
29
     
865
 
                 
Cash and Restricted Cash at Beginning of Period
   
1,153
     
619
 
Cash and Restricted Cash at End of Period
 
$
1,182
   
$
1,484
 
                 
Supplemental Information:
               
Cash paid for interest
 
$
908
   
$
2,045
 
                 
Non-cash Investing and Financing Activities:
               
Warrants issued in conjunction with senior secured promissory note payable and convertible promissory notes payable
 
$
570
   
$
2,654
 
Common shares issued for advisory shares
   
302
     
-
 
Embedded conversion feature on convertible promissory notess payable
   
157
         
Reclassification of warrant liability due to cashless warrant exercise
   
-
     
2,167
 
Common shares issued in conjunction with senior secured promissory note payable
   
-
     
3,720
 

The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.
 


v3.23.2
Document and Entity Information
Aug. 11, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 11, 2023
Entity File Number 000-52985
Entity Registrant Name SANUWAVE Health, Inc.
Entity Central Index Key 0001417663
Entity Incorporation, State or Country Code NV
Entity Tax Identification Number 20-1176000
Entity Address, Address Line One 11495 Valley View Road
Entity Address, City or Town Eden Prairie
Entity Address, State or Province MN
Entity Address, Postal Zip Code 55344
City Area Code 770
Local Phone Number 419-7525
Entity Emerging Growth Company false
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false

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